Clinical laboratories have multiple methods for diagnosing infectious disease, but the fact remains that despite culture, microscopy, antibody-based testing, and molecular testing such as PCR, up to 75 percent of infections are not diagnosed in a timely manner, if at all.1,2 One of the biggest issues is that a target is needed to know which test(s) can lead to an accurate diagnosis; the laboratorian must know what pathogen is suspected. And since many pathogens exhibit common symptoms, it is often difficult to determine an appropriate target.

The diagnostic challenges have resulted in a reliance on differential diagnosis and can result in spread of infectious diseases, longer hospital stays, more critical illnesses, longer recoveries, and compromised outcomes related to delayed or ineffective treatment. In addition, partly due to ineffective diagnostics, antibiotics are significantly overused in the United States. Such misuse of antibiotics is creating drug-resistant pathogens. According to the Centers for Disease Control and Prevention (CDC), “Each year in the United States, at least two million people become infected with bacteria that are resistant to antibiotics, and at least 23,000 people die each year as a direct result of these infections.”3

In the midst of these concerns is the reality that infectious disease outbreaks are no longer “local.” As large populations travel internationally, local authorities are often under-resourced in coping with identified outbreaks, and inadequate diagnostics and treatments leave us all more vulnerable. News headlines alert us to the Lyme disease season and to the risk of the Zika virus, while not so long ago people in Africa were dying by the thousands from Ebola. The confluence of all these factors makes it more important than ever to develop accurate and timely diagnostics for infectious diseases.